Assumption of regulatory roles

Medical technology start-ups often face the challenge of bringing their product to market as quickly as possible with limited human resources.

They often do not yet have the personnel / expertise on board to set up their own complete quality management system and the required regulatory processes.

It is also not always planned to set up a separate development and/or production area – for example, if the company is to be sold by the founders after the initial successes and the product ramp-up.

In such a case, seleon can assume the role of the legal manufacturer for a certain period of time or the entire product life cycle and relieve its customer.

However, such a solution can also be of interest to established medical device manufacturers when it comes to medical devices that complement their portfolio but are not part of their actual core business and they do not want to build up personnel / expertise for this.

Assuming the role of the legal manufacturer is not tied to the commissioning of a development and/or production project at seleon – but it makes the whole thing considerably easier, as we know the medical device we develop and/or manufacture best and are therefore best able to comprehend the risk structure.

Do you want to bring your medical devices into the European Union (EU)?

Then we are a trustworthy partner who meets the significantly increased requirements for the authorized representative (EC-REP) as a result of the MDR and IVDR very well thanks to our regulatory expertise and established processes.

We are happy to take on this important role for you and be your regulatory face in the European Union.